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Technical Services Lead (3 Year FTC)

Posted 58 minutes 45 seconds ago by 1100 Mylan Pharmaceuticals Inc.

Permanent
Full Time
Other
Galway, Galway, Ireland
Job Description

Mylan Teoranta Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

As Technical Services Lead, you will support the delivery of 3-year commercialization program for a new cartridge-filling product line and will be primarily responsible for activities related to product and process performance and for the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes, while ensuring compliance with cGMP and global regulatory expectations while driving process robustness, efficiency, and continuous improvement.

Every day, we rise to the challenge to make a difference and here's how the Technical Services Lead role will make an impact:

Lead process validation (PPQ) and ongoing process verification activities for sterile drug products

Ensure product and process-related technical services align with regulatory and internal standards

Lead design, development, and optimization of aseptic manufacturing processes for robustness, scalability, and efficiency

Define critical process parameters (CPPs) and critical quality attributes (CQAs) for manufacturing processes

Initiate and lead process risk assessments (FMEA, Ishikawa, etc.) and implement risk mitigation strategies

Analyze process and performance data to identify trends, reduce variability, and improve yield

Support investigations, root cause analyses, and CAPA implementation for process deviations or non-conformances

Lead the technical aspects of scale-up, technology transfer, and commercialization of new products

Collaborate with R&D, Manufacturing, Quality, Engineering and Regulatory Affairs to ensure smooth transitions from development to commercial production

Provide SME-level input into process validation protocols, batch records, and regulatory documentation

Identify qualification and validation requirements for new product introductions.

Stay current with evolving regulatory expectations (Annex 1, FDA, EMA, ICH Q8-Q10) and integrate best practices into process management.

Ensure completion of PPQs, transfers, and process improvement projects within agreed timelines

Maintain zero critical/major audit findings related to process validation or robustness

Demonstrate measurable gains in process consistency, quality, and productivity.

About Your Skills & Experience

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

Bachelor's or Master's degree in Pharmaceutical Science, Chemical/Biochemical Engineering, or related field.

Experience in pharmaceutical process development, technical services, or manufacturing, ideally in sterile injectables

Project Management Certified (would be an advantage)

Strong knowledge of aseptic processing, process validation (PPQ), and scale-up

Experience with DOE, SPC, and process modeling tools (e.g., Minitab)

Deep understanding of CPPs, CQAs, and control strategy design

Knowledge of microbiological principles and sterility assurance

Excellent analytical, problem-solving, and leadership skills

Proven ability to lead cross-functional teams and deliver complex technical project

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

Excellent career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.

If you would like to know more about what diversity, equity and inclusion means to us, please visit

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit

Viatr is an Equal Opportunity Employer.

Viatr is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

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